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โ† Trials
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FES Cycling With BFR in the Spinal Cord Injury Population

RecruitingPhase 1Ages 18 Years - 75 YearsAllDr. B. Catharine. Craven
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In plain words

What the trial is, and whether it could suit you

Cardiometabolic Disease (CMD) is the silent killer within the spinal cord injury/disease (SCI/D) population. Many SCI/D patients' initial CMD presentation is with a heart attack, stroke, or sudden cardiac death, highlighting the need for interventions to reduce CMD risk. CMD contributes to 46% of deaths, with 30-50% of the SCI/D population living with undiagnosed CMD. Treating CMD risk is more challenging in the SCI/D population due to prolonged inactivity, inability to exercise, and excessive caloric intake to expenditure ratio. Identifying accessible and inclusive strategies to combat CMD risk in the SCI/D population is a compelling and urgent health priority. Blood flow restriction (BFR) exercise involves applying inflatable cuffs to the proximal end of an individual's limbs. Changes to the amount of blood flowing into and out of the limb lead to a low oxygen environment within the l

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult (โ‰ฅ 18 to โ‰ค 75yrs) * Male or female * Chronic Injury (\>1yr) * Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology. * โ‰ฅ3 Cardiometabolic risk parameters Exclusion Criteria: * A prior or current history of venous thromboembolism * Pressure injury of the pelvis, mid to upper thigh region, or foot * Managing a lower limb fracture * Any history of embolic stroke * Myocardial infarction * Current untreated hypertension * Language, psychiatric, cognitive, or communicative disability (e.g., traumatic brain injury) that compromises the participant's autonomy to voluntarily join the study, follow its instructions and/or operate the device. * Current alcohol or street drug use disorder. * Current use of an anticoagulant medication. * Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week). * Unresolved deep vein thromboembolism (VTE) in the past six months. * Severe spasticity preventing the necessary range of motion for cycling. * Active implantable medical device (e.g., pacemaker, ITB pump). * Inability to provide informed consent. * Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores). * Unstable spine or unhealed limbs or pelvic fractures. * Active heterotopic ossification interfering with the lower extremity range of motion.
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What it tests

  • Blood Flow Restriction
  • Functional Electrical Stimulated Cycling
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Where

1 site
Lyndhurst Centre
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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